
Highly Skilled Data Specialist
1 week ago
About this Role
We are seeking a skilled professional to contribute to activities performed in our organization.
Responsibilities:
- To receive, process and enter safety information into our database, ensuring timely completion of tasks as required.
- Management of email boxes and registration of vigilance cases.
- Assignment, coordination and follow-up of vigilance cases, including requests with local reporters.
- Responding to queries from clients and reporters.
- To perform periodic reconciliations aimed at confirming the proper handling of vigilance reports.
- Support local pharmacovigilance activities as needed.
- To participate in audits / inspections.
Requirements:
- Bachelor's or Master's degrees in Medicine, Pharmacy, nursing, or science related field, or equivalent experience.
- 2+ years' experience in pharmacovigilance working for service providers performing data entry and QC of cases.
- Previous experience working under deadlines.
- Client communication skills.
- Knowledge of PV regulations.
- Pharmaceutical background – strong understanding of GVP, GCP, FDA requirements related to drug safety.
- Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment.
Skillset:
- Organizational and interpersonal skills.
- Ability to work well within a team.
- Time management skills.
- Accountability and autonomy with assigned tasks.
- Process orientated with attention to detail.
- Effective communications skills both written and verbal.
- Flexibility and adaptability to handle a dynamic workload.
- Works well under pressure and working to timelines.
- Safety database experience.
Benefits:
This role offers the opportunity to work in a dynamic environment, develop your skills and contribute to the success of our organization.
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